In this episode, hosts Marla Dalton, PE, CAE, and William Schaffner, MD, talk with Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration. He shares his insights on the origin of Operation Warp Speed during the COVID-19 pandemic, his efforts to transform the way that FDA approaches approval and licensure of new vaccines and other prevention tools, and his thoughts on how artificial intelligence may improve future work.Show notesBefore joining FDA, Dr. Marks was clinical director of hematology at Brigham and Women's Hospital in Boston, MA. He worked in industry for several years on hematology and oncology drug development and then returned to academic medicine at Yale University where he led the Adult Leukemia Service and served as chief clinical officer of Smilow Cancer Hospital. He joined FDA in 2012 as CBER deputy director and became director in2016. In 2022, he became a member of the National Academy of Medicine. Born in Brooklyn, NY, the father of 2 grown children now lives with his wife in Washington, DC.